The Recall Desk

Manufacturer

Abbott Laboratories, Inc.

32 recalls in our database name Abbott Laboratories, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
32
Critical
0
Severe
1
Most recent
2022-03-23

Of the 32 recalls from Abbott Laboratories, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (3%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 32

  • HighFDA (Devices)·Z-0749-2022·2022-03-23

    Abbott Alinity s System software error affects diagnostic analyzer wash cycle

    Abbott Laboratories is recalling 306 units of Alinity s System software version 2.8.0 due to a software error causing insufficient wash buffer volume, which could affect diagnostic test accuracy.

    Product
    Alinity s System software version2.8.0, REF LN 06P16-01, IVD, OEI: (01)00380740138479 The Alinity s System is intended for In Vitro diagnostic use only. The Alinity s System is a highthroughput, fully automated immunoassay analyzer designed to determine the presence of specifi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2276-2021·2021-08-18

    Automated diagnostic analyzer from Abbott recalled for waste pressure buildup

    Abbott is recalling 260 Alinity s System analyzers due to a design defect allowing waste pressure to build up and spray operators. No injuries reported.

    Product
    Alinity s System REF 06P16-01. An automated immunoassay analyzer for In Vitro diagnostic use in blood donor screening, plasma and plasmapheresis screening, and organ donor centers, hospitals, and reference laboratories.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1671-2020·2020-04-15

    Abbott ARCHITECT C System Mixer Recall Due to Blade Separation Risk

    Abbott is recalling ARCHITECT C System Mixers because the blade may separate from the mixer due to screw and nut failure, leading to inadequate mixing of samples and reagents.

    Product
    ARCHITECT C System Mixer - Product Usage: The ARCHITECT Clinical Chemistry System is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The mixer is a component and it is used on all ARCHITECT Clinical Chemistry systems to mix the s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2755-2019·2019-10-02

    Abbott APS Accelerator Modules Recalled for Missing Pacemaker Safety Label

    Abbott is recalling 159 APS Accelerator modular systems because the safety pacemaker label is missing. The Operations Manual has been updated to specify a 200 mm minimum safety distance for pacemaker wearers.

    Product
    APS Accelerator modular systems, 208-230 V-, 50/60 Hz, 1800 VA, IVD, RX, Class 2 Laser Product,
    Category
    Medical Device
    Distribution
    21 states
  • ModerateFDA (Devices)·Z-1993-2019·2019-07-31

    Abbott Haptoglobin Assay Recalled for Instruction Manual Updates

    Abbott Laboratories is recalling 5,694 Haptoglobin Assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.

    Product
    The,K -ASSAY HP assay is intended for the quantitative determination of human haptoglobin by immunoturbidimetric assay. The antiserum used in the kit was produced against purified human haptoglobin. The haptoglobin antibody interacts with the haptoglobin in the serum forming i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1989-2019·2019-07-31

    Abbott Immunoglobulin G Diagnostic Assay Recall for IFU Updates

    Abbott Laboratories is recalling 11,063 Immunoglobulin G in vitro diagnostic kits to update instructions for use regarding reagents and specimen handling.

    Product
    Immunoglobulin G is an in vitro diagnostic assay for the quantitative determination of immunoglobulin G in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1987-2019·2019-07-31

    Abbott C3 In Vitro Diagnostic Assay Recall for Instruction Manual Update

    Abbott Laboratories is recalling 8,132 C3 in vitro diagnostic kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.

    Product
    C3 is an in vitro diagnostic assay for the quantitative determination of C3 in human serum or plasma. Antibodies to C3 combine with C3 in the sample to form insoluble immune complexes. The immune complexes cause an increase in light scattering (turbidity). The resulting increa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1990-2019·2019-07-31

    Abbott Immunoglobulin M Diagnostic Assay Recalled for Instruction Manual Errors

    Abbott Laboratories is recalling 9,586 Immunoglobulin M diagnostic kits because the instructions for use contained errors in the reagents and specimen handling sections.

    Product
    Immunoglobulin M is an in vitro diagnostic assay for the quantitative determination of immunoglobulin M in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1991-2019·2019-07-31

    Abbott Apolipoprotein A1 Assay Recalled for Instruction Manual Updates

    Abbott Laboratories is recalling 2,112 Apolipoprotein A1 assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.

    Product
    Apolipoprotein A1 is an in vitro diagnostic assay for the quantitative determination of apolipoprotein A1 in human serum or plasma. Antibodies to apolipoprotein A1 combine with apolipoprotein A1 in the sample to form insoluble immune complexes. The immune complexes cause an incr
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1994-2019·2019-07-31

    Abbott Apolipoprotein B Assay Recalled for Instruction Manual Updates

    Abbott Laboratories is recalling 2,273 Apolipoprotein B in vitro diagnostic kits because the Instructions for Use (IFU) required updates to reagent and specimen handling sections.

    Product
    Apolipoprotein B is an in vitro diagnostic assay for the quantitative determination of apolipoprotein B in human serum or plasma. Antibodies to apolipoprotein B combine with apolipoprotein B in the sample to form insoluble immune complexes. The immune complexes cause an increa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1988-2019·2019-07-31

    Abbott Immunoglobulin A Diagnostic Assay Recalled for Instruction Manual Errors

    Abbott Laboratories is recalling 12,995 Immunoglobulin A diagnostic kits because the instructions for use contained errors in the reagents and specimen handling sections.

    Product
    Immunoglobulin A is an in vitro diagnostic assay for the quantitative determination of immunoglobulin A in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1995-2019·2019-07-31

    Abbott Transferrin Assay Recalled for Instruction Manual Updates

    Abbott Laboratories is recalling 22,359 Transferrin in vitro diagnostic kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.

    Product
    Transferrin is an in vitro diagnostic assay for the quantitative determination of transferrin in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1992-2019·2019-07-31

    Abbott C4 In Vitro Diagnostic Assay Recall for Instruction Manual Updates

    Abbott Laboratories is recalling 8,037 C4 in vitro diagnostic assay kits to update the Instructions for Use (IFU) regarding reagents and specimen handling.

    Product
    C4 is an in vitro diagnostic assay for the quantitative determination of C4 in human serum or plasma. Antigen in the sample bonds to the specific antibody in the reagent, forming an immune complex. The immune complex causes an increase in light scattering, measured by reading t
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1296-2019·2019-05-15

    Abbott ARCHITECT cSystems ICT Module Recall for False Chloride Results

    Abbott is recalling ARCHITECT cSystems ICT Modules due to a potential for falsely elevated serum or plasma chloride results.

    Product
    Abbott ARCHITECT cSystems ICT Module, REF 09D28-03. Product Usage: The ARCHITECT cSystems ICT (Integrated Chip Technology) is used for the quantitation of sodium, potassium, and chloride in human serum, plasma, or urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1104-2019·2019-04-17

    Abbott ARCHITECT c16000 Processing Module Recalled for Potential Incorrect Results

    Abbott Laboratories is recalling 1,666 ARCHITECT c16000 Processing Modules worldwide because unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c16000 Processing Module, List No. 03L77 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potenti
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1102-2019·2019-04-17

    Abbott ARCHITECT c4000 Processing Module Recalled for Potential Incorrect Results

    Abbott Laboratories is recalling 3,675 ARCHITECT c4000 Processing Modules because specific unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c4000 Processing Module, List No. 02P24 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1103-2019·2019-04-17

    Abbott ARCHITECT c8000 Processing Module Recall for Potential Incorrect Results

    Abbott is recalling 3,794 ARCHITECT c8000 Processing Modules because unresolved error codes may cause the instrument to generate incorrect diagnostic results.

    Product
    Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentio
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1075-2019·2019-04-10

    Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues

    Abbott Laboratories is recalling specific lots of ARCHITECT Creatine Kinase IVD kits due to a stability issue that may cause error codes or out-of-range quality control results.

    Product
    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D63-21.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1076-2019·2019-04-10

    Abbott ARCHITECT Creatine Kinase IVD Recalled for Stability Issues

    Abbott Laboratories is recalling 30 kits of ARCHITECT Creatine Kinase IVD due to a stability issue that may cause error codes or out-of-range quality control results.

    Product
    Abbott ARCHITECT Creatine Kinase, IVD, REF 7D6341.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0971-2019·2019-03-13

    Abbott Recalls Architect Magnesium Assay Due to Depressed Urine Results

    Abbott is recalling Architect Magnesium assays because urine tests may show falsely low results. The recall covers 24,995 units distributed in the US and four other countries.

    Product
    ARCHITECT MAGNESIUM, (a) REF 7D70-21, (b) 7D70-31 The Magnesium assay is used for the quantitation of magnesium in human serum, plasma, or urine.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2522-2018·2018-08-01

    Abbott Recalls CardioMEMS Electronics Units Due to False Error Messages

    Abbott is recalling 2,521 CardioMEMS Patient and Hospital Electronics Units because they may display a false Error 5 message due to a configuration defect.

    Product
    CardioMEMS HF System Hospital and Patient Electronics Units: (a) Patient Electronics System, Model CM1100 (b) Hospital Electronics System, Model CM3000
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0922-2018·2018-03-14

    Abbott ARCHITECT c8000 Cuvette Segment Recall for False Test Results

    Abbott is recalling ARCHITECT c8000 Cuvette Segments because a detached post can cause falsely depressed patient results on c4000, c8000, and c16000 instruments.

    Product
    ARCHITECT c8000 Cuvette Segment, Part #01G46-01/01G06, a component to the ARCHITECT Clinical Chemistry system. There are 11 segments with each cuvette segment holding 15 cuvettes for a total of 165 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratorie
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0923-2018·2018-03-14

    Abbott Recalls ARCHITECT c16000 Cuvette Segments Due to Falsely Depressed Results

    Abbott Laboratories is recalling cuvette segments for the ARCHITECT Clinical Chemistry system because detached segment posts may cause falsely depressed patient test results.

    Product
    ARCHITECT c16000 Cuvette Segment, Part #09D32-05/ 03L77, a component to the ARCHITECT Clinical Chemistry system. There are 15 segments with each cuvette segment holding 11 cuvette pairs (22 cuvettes) for a total of 165 cuvettes pairs or a total of 330 cuvettes (22 cuvettes x 15
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0921-2018·2018-03-14

    Abbott ARCHITECT c4000 Cuvette Segment Recall for Potential False Results

    Abbott is recalling ARCHITECT c4000 Cuvette Segments because a detached post can cause falsely depressed patient results in adjacent cuvettes.

    Product
    ARCHITECT c4000 Cuvette Segment, Part #02P75-01/02P24, a component to the ARCHITECT Clinical Chemistry system. There are 9 segments with each cuvette segment holding 11 cuvettes for a total of 99 cuvettes per reaction carousel. The firm name on the label is Abbott Laboratories,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0166-2018·2017-11-29

    Abbott Peristaltic Head Tubing Recalled for Potential Leaking

    Abbott Laboratories is recalling Peristaltic Head tubing for clinical chemistry systems due to a manufacturing issue that may cause the tubing to leak.

    Product
    Tubing, Peristaltic Head Part Number 7-35009685-01 for use in clinical chemistry systems.
    Category
    Medical Device
    Distribution
    0 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Abbott Laboratories

American global health care and medical device products company

Country
United States
Founded
1888

Official website

Source: Wikidata (Q306764), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.